(39 days)
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No
The document describes a standard panoramic/cephalometric X-ray unit with microprocessor control and film handling. There is no mention of AI, ML, or advanced image processing techniques typically associated with these technologies. The description focuses on the mechanical and basic electronic functions of the device.
No
The device is described as being used for diagnostic radiographic purposes (e.g., producing X-rays for diagnosis), not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "will be marketed for diagnostic radiographic use." Additionally, the "Device Description" mentions that the X-ray source and film rotate "so as to produce a panoramic film for diagnostic use."
No
The device description explicitly states it is an "X-ray generator and film handling unit," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic radiographic use in dental, oral surgery, and orthodontic practices... to produce a panoramic film for diagnostic use." This describes an imaging device used to capture images of the patient's anatomy.
- Device Description: The description details an "X-ray generator and film handling units" that produce a "panoramic film." This is consistent with an imaging system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used to create images of the body itself.
N/A
Intended Use / Indications for Use
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.
Product codes
76EHD
Device Description
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric Xray Units are microprocessor controlled X-ray generator and film handling units designed mainly for dental applications. The patient stands facing the unit and is positioned by devices built into the unit. The exposure is begun under control of the operator, and the X-ray source and film rotate so as to produce a panoramic film for diagnostic use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
Dental
Indicated Patient Age Range
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Intended User / Care Setting
Dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
JAN 2 4 1997
EXHIBIT A
Kavcor International Ltd. 3611 Commercial Avenue Northbrook, IL 60062 USA 847-564-4334 Fax: 847-564-9040 Contact Name: Keith R. Kretchmen December 18, 1996
510(k) Summary of Safety and Effectiveness
Identification of the Device 1.
Classification Name: Extraoral source X-ray system, 76EHD, Reg. # 872.1800
Common/Usual Name: Panoramic dental X-ray system
Proprietary-Trade Name; Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric X-ray Unit.
2. Equivalent legally marketed devices
This product is similar in design and function to the Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit, and Yoshida Kaycor Panoura-10C Panoramic/Cephalometric Xray Unit. (K811210)
3. Indications for Use (intended use)
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.
- Description of the Device:
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric Xray Units are microprocessor controlled X-ray generator and film handling units designed mainly for dental applications. The patient stands facing the unit and is positioned by devices built into the unit. The exposure is begun under control of the operator, and the X-ray source and film rotate so as to produce a panoramic film for diagnostic use.
1
ડ. Safety and Effectiveness, comparison to predicate device.
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric Xray Units, are substantially equivalent to the Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit, and Yoshida Kaycor Panoura-10C Panoramic/Cephalometric X-ray Units, and are substantially equivalent in safety and effectiveness. Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical. The chart below compares the new and predicate devices.
6. Substantial Equivalence Chart
| Feature | Panoura ULTRA Pan
and Panoura ULTRA
Pan/Ceph
(new device) | Panoura-10 Series
(predicate device) |
|--------------------------|--------------------------------------------------------------------|--------------------------------------------|
| X-ray output | | |
| Panoramic mode | 6 mA @ 70-90 kVp in 6 steps | 6 mA @ 70-90 kVp
continuously variable |
| Cephalometric mode | 10 mA @ 70-90 kVp in 6 steps | 10 mA @ 70-90 kVp
continuously variable |
| Timer | | |
| Panoramic mode | 12, 14, or 16 seconds | 12 seconds |
| Cephalometric mode | 0.05-4.0 sec., 28 steps | 0.4-5.0 sec., 12 steps |
| X-ray generator | Self-rectified, 50/60 Hz | Self-rectified, 50/60 Hz |
| X-ray tube | Superior SXR-15 or equal | Toshiba D-103S or equal |
| Focal spot size | 1.0 mm | 1.0 mm |
| Total filtration | 2.8 mm Al equiv. | 2.8 mm Al. equiv. |
| Footprint, panoramic | 34.06" (86.5 cm) W,
40.0" (101.4 cm) D | 34.5" (87.63 cm) W,
41.0" (104.14 cm) D |
| Footprint, cephalometric | 72.0" (182.88 cm) W,
40.0" (101.4 cm) D | 72.0" (182.88) W,
41.0" (104.14 cm) D |
| Control display | Digital | Analog |
| Maximum tube voltage | 90 kVp | 90 kVp |
| Maximum tube current | | |
| Panoramic | 6 mA | 6 mA |
| Cephalometric | 10 mA | 10 mA |
7. Conclusion
Since there are no new indications for use nor are there any new potential hazards and preproduction testing showed that radiographs of the same patient produced on either device were essentially identical, Kaycor is of the opinion that the devices are substantially equivalent